From bench to bedside
Manique Wijesinghe explains how new drugs become licensed and how the pharmaceutical industry ensures a good return from its investment
- By: Manique Wijesinghe
Pharmaceutical innovations in the past several decades have accounted for vast improvements in public health the world over. In 2003, 650 million prescription items were dispensed in the United Kingdom. And the pharmaceutical industry has been described as “a jewel in the crown of the UK economy.”1 The NHS spent more than £7bn ($13bn; a10bn) on drugs in 2003, and branded drugs accounted for 80% of this figure (box).1
Drug research and development is a costly and uncertain process. Many new molecular entities fail stringent tests for safety and efficacy (figure 2).
Phase I, II, and III trials are done before a marketing licence is granted, but phase IV trials form a postmarketing surveillance system. Adverse drug reactions in this time should be reported to the country's drug licensing authority—in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) and in the United States, the Food and Drug Administration.1